HIGHFDA DEVICE

Philips Recalls Allura Xper FD10F Systems Due to Electrical Hazard

Philips Medical Systems recalled 12 Allura Xper FD10F systems on December 15, 2025, after identifying a potential electrical hazard. The drip tray beneath the cooling unit may not have been installed correctly, posing a risk of coolant leakage and electrical short-circuits. Users must stop using the device immediately and follow recall instructions.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesModel Number: 722002System Product Name: Allura Xper FD10FUDI-DI: N/A

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 15, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 15, 2025
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product type
Medical Imaging System
Model numbers
Model Number: 722002, System Product Name: Allura Xper FD10F, UDI-DI: N/A, Serial Numbers: 61, 56, 27, 81, 25 +7 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 15, 2025

  2. Reported by FDA DEVICE

    January 21, 2026

  3. RecallRadar source check

    January 28, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter

About This Product

The Allura Xper FD10F is a medical imaging system used in healthcare settings for diagnostic purposes. It provides critical imaging capabilities for various medical procedures.

Why This Is Dangerous

The hazard arises from the potential failure to install the drip tray, which can allow coolant to leak onto electrical components. This may lead to short-circuits and system failures, posing a risk to patients and medical personnel.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall necessitates immediate action from healthcare providers to avoid potential equipment failure during medical procedures, which can disrupt patient care.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the device to confirm it is 722002.
  2. Look for any documentation regarding previous field corrections related to the drip tray.
  3. Contact Philips for further verification if unsure.

Where to find product info

The model number can typically be found on the device's label or user manual.

What timeline to expect

Expect refund processing to take approximately 4-6 weeks after submission of your request.

If the manufacturer is unresponsive

  • Document all correspondence with Philips regarding the recall.
  • Follow up via phone or email if a response is not received within two weeks.

How to prevent similar issues

  • Always verify the installation of safety components on medical devices.
  • Stay informed about recalls through manufacturer websites and healthcare channels.
  • Regularly participate in safety training provided by healthcare institutions.

Documentation advice

Keep records of correspondence with Philips, including dates, names, and any reference numbers.

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Product Details

The recalled product is the Allura Xper FD10F, Model Number 722002. It was distributed worldwide, including the US and multiple countries. This recall affects 12 units.

Key Facts

  • Recall date: December 15, 2025
  • Report date: January 21, 2026
  • Quantity recalled: 12 units
  • High hazard level
  • Affected model: Allura Xper FD10F, Model Number 722002

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Classification

Product Details

Model Numbers
Model Number: 722002
System Product Name: Allura Xper FD10F
UDI-DI: N/A
Serial Numbers: 61
56
+10 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Philips Medical Systems Recalls Azurion 5 M12 Over Safety Risk

Philips Medical Systems recalled 326 Azurion 5 M12 systems on January 26, 2026. The table may move unexpectedly when the Reset Geometry button is pressed, posing a risk to patients and healthcare providers. Immediate cessation of use is advised.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Under certain
Read more